AI-assisted T-staging for gastric cancer with radiology guidance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The TRACE trial is a prospective, randomized crossover study that compares AI-assisted versus standard radiology readings for preoperative gastric cancer T-staging on contrast-enhanced CT. Radiologists interpret 60 cases twice, with and without TRACE support, in random order and with a washout period to reduce memory effects. The primary goal is to see if AI guidance improves staging accuracy, while secondary outcomes include agreement between readers, reading time, and confidence. Participants are pathologically confirmed gastric cancer cases, and readers remain blinded to reference standards. The trial uses a crossover design and plans subgroup analyses by tumor location, T category, and reader experience.

Why it matters

Who can join: the full rules

Inclusion Criteria (Imaging Data)

1. Contrast-enhanced CT (CE-CT) images of gastric cancer patients from the Liaoning Cancer Hospital;
2. Patients with a definitive postoperative pathological diagnosis of gastric cancer and a clear T-stage classification (T1-T4, including T4a and T4b);
3. Imaging data must be complete and of sufficient quality to meet diagnostic and analytical requirements, with no significant artefacts or missing key data;
4. Complete clinical and pathological information must be available to establish a diagnostic gold standard for comparison.

Physician Inclusion Criteria (Image Readers)

1. Radiologists holding a valid medical licence;
2. From the radiology department of a Grade A tertiary hospital or a non-Grade A tertiary hospital;
3. Classified as senior or junior physicians based on clinical experience;
4. Voluntarily participating in this study and completing both the non-AI-assisted and AI-assisted image interpretation tasks.

Case Exclusion Criteria

1. Severe missing imaging data or quality failing to meet analysis requirements (e.g., severe motion artefacts);
2. Lack of clear postoperative pathological T-staging results;
3. Cases not involving gastric cancer or with incomplete pathological information;
4. Cases of duplicate enrolment or inconsistent data recording.

Physician Exclusion Criteria

1. Those unable to complete all image review tasks or demonstrating severe non-compliance;
2. Those who withdraw during the study period and are unable to provide complete data for both phases of image review;
3. Those who fail to complete the AI-assisted and non-AI-assisted interpretation processes as specified.

Withdrawal Criteria

1. Physicians who voluntarily withdraw from the study for personal reasons (e.g., time, health or work commitments);
2. Physicians who fail to complete the required image review tasks or have data missing in excess of the specified threshold;
3. Cases where critical data errors are identified during subsequent verification or where pathological results cannot be traced; Data found during the study to be non-compliant with ethical or quality control requirements must be excluded.

Where it's running

• Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
  Shenyang, Liaoning, China Recruiting

Study contacts

• Principal investigator: Guoliang Zheng — Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
• Study coordinator: Guoliang Zheng
• Email: zhengboren1@126.com
• Phone: 13322400728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.